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临床试验/CTRI/2018/08/015533
CTRI/2018/08/015533已完成2 期

“An Open Clinical Study to Evaluate the Efficacy of Shirobasti and Nasya With and Without Levodopa in the Management of Kampavata w.s.r. to Parkinson’s Disease (PD).

National Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年4月7日最近更新:

试验速览

阶段
2 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Assessment of changes in specific signs and symptoms of Kampavata/PD.

研究概览

简要总结

Parkinson’s disease (PD) is the most common form of a group of progressive neurodegenerative disorders characterized by bradykinesia, rest tremors, muscular rigidity, shuffling gait and flexed posture. Most of the features match with the Ayurvedic description of KAMPAVATA. Worldwide incidence of PD is estimated to be around 7 to 10 million. Acharaya Charaka noted tremors in different organs like head. Various synonyms used are “Kampanaâ€, “Vepanaâ€, “Vepathuâ€, and “Spandana†all indicating tremors of varying nature and severity. Majority of symptoms of Kampavata are mentioned in different Avaranas, Charaka says that Avarana of Vyana and Udana by Kapha produces symptoms like Gatisanga, Vakswaragraha, Gurugatrata, Stambana and KampanaPanchkarma procedures are especially advocated in the treatment of neurological diseases. Different types of Snehana, Swedana are efficacious. Besides a special treatment like Shirobasti, Shirodhara, Nasya and Basti karma are indicated in such diseases. Among the management of Vata vyadhis very less work has been carried out in management of Kampavata. Most of the Vata vyadhis are not curable but the patient may be able to live with the diseases with certain degree of inconvenience and difficulties as long as he or she lives. Thus an effort is made to evaluate the synergetic effect of Shirobasti and Nasya in *Kampavata/*PD.

In the presentstudy the patients will be selected from OPD & IPD of NIA, Jaipur (Raj.), SS Bombaywala-NIA City Hospital, Jaipur (Raj.) and SMS Hospital, Department of Neurology, Jaipur (Raj.). Minimum 30 patients of either sex who fulfill the inclusion criteria or diagnosed cases will be included in the study and cases registered for the study will be divided into two groups, having 15 cases in each group.In  group A patient those receiving Levodopa in fixed dose will be undergone Shirobasti and Nasya with Ksheerbala Taila for 14 days. In group B patient those not taking Levodopa  will be undergone Shirobasti and Nasya with Ksheerbala Taila for 14 days. ***Shirobasti-***The oil is poured on to the head is allowed to remain there for certain period, and this procedure of Murdha Taila is called as Shirobasti. To be more precise, a special hat, preferably made of leather is fixed around the head just above the ear and eyebrow, and the joint between the head and hat is made leak proof. On to this positioned hat lukewarm oil is poured, and then is allowed to remain there for about 45-50 minutes (53 minutes in case of vataja vikaras, 43 minutes in pittaja vikaras and 31 minutes in case of kaphaja vikaras). This therapeutic procedure of Bhaya sneha to the head is referred as Shirobasti. This is then followed by Shiro-abhyanga.  ***Nasya -***After Abhyanga and Svedana of Uttamanga, Nasya with Ksheerbala Taila is administered with the help of dropper, 8 (eight) drops to each nostril.

**TRIAL DRUG –**Ksheerbala Taila for Shirobasti and Nasya both.The Subjective and objective parameters of base line data to post procedural data will be compared for assessment on the basis of UPDRS scale (Unified Parkinson Disease Rating Scale) (modified) before and after the treatment. All the results will be analyzed statistically.

**CONCLUSION:**The present study has been entitled as “An Open Clinical Study to Evaluate the Efficacy of Shirobasti and Nasya With and Without Levodopa in the Management of Kampavata w.s.r. to Parkinson’s disease (PD)â€. Based on the literature and observations made in this clinical study, following conclusions can be drawn. Kampavata bears a resemblance to the clinical features of Parkinson’s disease (PD).   Kampavata being a Vata Vyadhi, Brihmana is best suitable therapy and both Shirobasti and Tarpana Nasya are best recommended in reducing stress in the patients of Kampavata (PD) as both the procedures are non-invasive, outpatient procedures with minimal discomfort.

Observations and results of the present study holds the explanation of the Modern and Ayurveda literatures and also supports the results of the previous work done.Specific etiology was not found in any of the patients considered for the present study but Mansika Hetu was found in most of the patients. Maximum results were found in Mentation, Behaviour and mood of UPDRS scale. The comparative effect of both the procedures showed more significant results in Group B (without levodopa) than Group A (with levodopa).

In Group A, significant results were found in Stambha, Gativikriti, Avanamana, ADL, Motor Examination, Schwab and England ADL scale and in Group B, significant results were found in Kampa, Chestasanga, Vakavikriti, Mentation, Behaviour and mood, Modified Hoehn and Yahr Staging.

Therefore, it can be concluded that the Shirobasti and Nasya show improvement in the signs and symptoms of Kampavata (PD) in both the groups. Both the procedures are efficacious in reducing Activities of Daily Living, thereby improving quality of life.

Suggestions for further studies;

1.       Study on large samples.

2.       Study of both the procedures repeatedly in a year for 3-4 times.

3.       Standardization of both the procedures in the patients of Kampavata (PD).

4.       Study in the management of Kampavata (PD) with other Panchkarma procedures.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Open Label

入排标准

年龄范围
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients between 40-70 years of age.
  • 2.Patients with clinical signs and symptoms of Kampavata/ PD.
  • 3.Patients of either sex irrespective of their occupation, religion and socio-economic status.
  • 4.Patients of kampavata/PD who are on a fixed dose of levodopa and fit for Shirobasti and Nasya.
  • 5.Patients of kampavata/PD who are not on levodopa and fit for Shirobasti and Nasya.
  • 6.Patients willing to participate for interventional study.

排除标准

  • 1.Patients with severe systemic disorders as Uncontrolled Hypertension, Cardiac Problem, Diabetes Mellitus, Tuberculosis, Leprosy, Paralysis, malignant disease etc.
  • 2.Patients unfit for Shirobasti and Nasya.

结局指标

主要结局

Assessment of changes in specific signs and symptoms of Kampavata/PD.

时间窗: 45 days

次要结局

  • Any adverse effect in the values of hematological test and in clinical signs and symptoms.(45 days)

研究者

申办方类型
Government medical college

研究点 (1)

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